NCT06082011

A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries(SPiM-RWS-GYN)

A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

Study name：A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries Study purpose：This clinical trial is a real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port robotic surgeries of gynecological benign and malignant tumors in the real world, providing a real world evidence for clinical application of the product in the Chinese population. Study design：Retrospective + prospective, real-world study English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.

Conditions

• Gynecological Surgeries

Interventions

Type	Name	Description
DEVICE	da Vinci SP Surgical System	Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.

Timeline

• Start date: 2023-03-28
• Primary completion: 2024-10-31
• Completion: 2024-12-31
• First posted: 2023-10-13
• Last updated: 2023-10-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study